Clinical experience with three-factor prothrombin complex concentrate to reverse warfarin anticoagulation in intracranial hemorrhage

Jeffrey A Switzer, Jody Rocker, Phillip Mohorn, Jennifer L Waller, Douglas Hughes, Askiel Bruno, Fenwick T Nichols, David C Hess, Kavita Natrajan, Susan C. Fagan

Research output: Contribution to journalReview article

31 Citations (Scopus)

Abstract

BACKGROUND AND PURPOSE-: The effectiveness of prothrombin complex concentrate (PCC) products available in the United States that contain low levels of factor VII (3-factor PCC) has not been tested. The purpose of this study was to review our experience with 3-factor PCC (Profilnine) in the setting of warfarin-associated intracranial hemorrhage (wICH). METHODS-: In November 2007, we implemented a protocol for reversal of anticoagulation in wICH using Profilnine. Additional treatment with fresh-frozen plasma was at the discretion of the treating physician. Medical records of all patients receiving PCC for wICH between November 1, 2007, and December 7, 2011 were reviewed. Correction of the international normalized rate (INR) was defined as an INR <1.4. RESULTS-: Seventy wICH patients were treated with Profilnine, including 46 (66%) with intraparenchymal hemorrhage, 22 (31%) with subdural hemorrhage, and 2 (3%) with subarachnoid hemorrhage. Mean INR was reduced from 3.36 to 1.96, and in 44 (62.9%) patients the INR corrected to <1.4. Baseline INR ≥3.0 decreased the likelihood of INR correction. Concomitant administration of fresh-frozen plasma (mean, 2.6 U) did not increase the likelihood of INR correction. Seven (10%) patients had serious adverse events during their hospital course, including 2 sudden deaths from suspected pulmonary embolism. CONCLUSIONS-: Reversal of coagulopathy in wICH with Profilnine was incomplete and associated with serious adverse events. In the absence of available 4-factor PCC, options for urgent reversal of anticoagulation in wICH remain limited.

Original languageEnglish (US)
Pages (from-to)2500-2502
Number of pages3
JournalStroke
Volume43
Issue number9
DOIs
StatePublished - Sep 1 2012

Fingerprint

Intracranial Hemorrhages
Warfarin
Subdural Hematoma
Factor VII
Subarachnoid Hemorrhage
Sudden Death
Pulmonary Embolism
Medical Records
prothrombin complex concentrates
Hemorrhage
Physicians

Keywords

  • acute
  • intracranial hemorrhage
  • warfarin

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Clinical Neurology
  • Advanced and Specialized Nursing

Cite this

Clinical experience with three-factor prothrombin complex concentrate to reverse warfarin anticoagulation in intracranial hemorrhage. / Switzer, Jeffrey A; Rocker, Jody; Mohorn, Phillip; Waller, Jennifer L; Hughes, Douglas; Bruno, Askiel; Nichols, Fenwick T; Hess, David C; Natrajan, Kavita; Fagan, Susan C.

In: Stroke, Vol. 43, No. 9, 01.09.2012, p. 2500-2502.

Research output: Contribution to journalReview article

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title = "Clinical experience with three-factor prothrombin complex concentrate to reverse warfarin anticoagulation in intracranial hemorrhage",
abstract = "BACKGROUND AND PURPOSE-: The effectiveness of prothrombin complex concentrate (PCC) products available in the United States that contain low levels of factor VII (3-factor PCC) has not been tested. The purpose of this study was to review our experience with 3-factor PCC (Profilnine) in the setting of warfarin-associated intracranial hemorrhage (wICH). METHODS-: In November 2007, we implemented a protocol for reversal of anticoagulation in wICH using Profilnine. Additional treatment with fresh-frozen plasma was at the discretion of the treating physician. Medical records of all patients receiving PCC for wICH between November 1, 2007, and December 7, 2011 were reviewed. Correction of the international normalized rate (INR) was defined as an INR <1.4. RESULTS-: Seventy wICH patients were treated with Profilnine, including 46 (66{\%}) with intraparenchymal hemorrhage, 22 (31{\%}) with subdural hemorrhage, and 2 (3{\%}) with subarachnoid hemorrhage. Mean INR was reduced from 3.36 to 1.96, and in 44 (62.9{\%}) patients the INR corrected to <1.4. Baseline INR ≥3.0 decreased the likelihood of INR correction. Concomitant administration of fresh-frozen plasma (mean, 2.6 U) did not increase the likelihood of INR correction. Seven (10{\%}) patients had serious adverse events during their hospital course, including 2 sudden deaths from suspected pulmonary embolism. CONCLUSIONS-: Reversal of coagulopathy in wICH with Profilnine was incomplete and associated with serious adverse events. In the absence of available 4-factor PCC, options for urgent reversal of anticoagulation in wICH remain limited.",
keywords = "acute, intracranial hemorrhage, warfarin",
author = "Switzer, {Jeffrey A} and Jody Rocker and Phillip Mohorn and Waller, {Jennifer L} and Douglas Hughes and Askiel Bruno and Nichols, {Fenwick T} and Hess, {David C} and Kavita Natrajan and Fagan, {Susan C.}",
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T1 - Clinical experience with three-factor prothrombin complex concentrate to reverse warfarin anticoagulation in intracranial hemorrhage

AU - Switzer, Jeffrey A

AU - Rocker, Jody

AU - Mohorn, Phillip

AU - Waller, Jennifer L

AU - Hughes, Douglas

AU - Bruno, Askiel

AU - Nichols, Fenwick T

AU - Hess, David C

AU - Natrajan, Kavita

AU - Fagan, Susan C.

PY - 2012/9/1

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N2 - BACKGROUND AND PURPOSE-: The effectiveness of prothrombin complex concentrate (PCC) products available in the United States that contain low levels of factor VII (3-factor PCC) has not been tested. The purpose of this study was to review our experience with 3-factor PCC (Profilnine) in the setting of warfarin-associated intracranial hemorrhage (wICH). METHODS-: In November 2007, we implemented a protocol for reversal of anticoagulation in wICH using Profilnine. Additional treatment with fresh-frozen plasma was at the discretion of the treating physician. Medical records of all patients receiving PCC for wICH between November 1, 2007, and December 7, 2011 were reviewed. Correction of the international normalized rate (INR) was defined as an INR <1.4. RESULTS-: Seventy wICH patients were treated with Profilnine, including 46 (66%) with intraparenchymal hemorrhage, 22 (31%) with subdural hemorrhage, and 2 (3%) with subarachnoid hemorrhage. Mean INR was reduced from 3.36 to 1.96, and in 44 (62.9%) patients the INR corrected to <1.4. Baseline INR ≥3.0 decreased the likelihood of INR correction. Concomitant administration of fresh-frozen plasma (mean, 2.6 U) did not increase the likelihood of INR correction. Seven (10%) patients had serious adverse events during their hospital course, including 2 sudden deaths from suspected pulmonary embolism. CONCLUSIONS-: Reversal of coagulopathy in wICH with Profilnine was incomplete and associated with serious adverse events. In the absence of available 4-factor PCC, options for urgent reversal of anticoagulation in wICH remain limited.

AB - BACKGROUND AND PURPOSE-: The effectiveness of prothrombin complex concentrate (PCC) products available in the United States that contain low levels of factor VII (3-factor PCC) has not been tested. The purpose of this study was to review our experience with 3-factor PCC (Profilnine) in the setting of warfarin-associated intracranial hemorrhage (wICH). METHODS-: In November 2007, we implemented a protocol for reversal of anticoagulation in wICH using Profilnine. Additional treatment with fresh-frozen plasma was at the discretion of the treating physician. Medical records of all patients receiving PCC for wICH between November 1, 2007, and December 7, 2011 were reviewed. Correction of the international normalized rate (INR) was defined as an INR <1.4. RESULTS-: Seventy wICH patients were treated with Profilnine, including 46 (66%) with intraparenchymal hemorrhage, 22 (31%) with subdural hemorrhage, and 2 (3%) with subarachnoid hemorrhage. Mean INR was reduced from 3.36 to 1.96, and in 44 (62.9%) patients the INR corrected to <1.4. Baseline INR ≥3.0 decreased the likelihood of INR correction. Concomitant administration of fresh-frozen plasma (mean, 2.6 U) did not increase the likelihood of INR correction. Seven (10%) patients had serious adverse events during their hospital course, including 2 sudden deaths from suspected pulmonary embolism. CONCLUSIONS-: Reversal of coagulopathy in wICH with Profilnine was incomplete and associated with serious adverse events. In the absence of available 4-factor PCC, options for urgent reversal of anticoagulation in wICH remain limited.

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